Cleared Traditional

K883909 - SURGICAL SPRING CLIPS
(FDA 510(k) Clearance)

K883909 · Applied Vascular Devices, Inc. · Cardiovascular
Dec 1988
Decision
103d
Days
Class 2
Risk

K883909 is an FDA 510(k) clearance for the SURGICAL SPRING CLIPS. This device is classified as a Clip, Vascular (Class II — Special Controls, product code DSS).

Submitted by Applied Vascular Devices, Inc. (Santa Ana, US). The FDA issued a Cleared decision on December 27, 1988, 103 days after receiving the submission on September 15, 1988.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3250.

Submission Details

510(k) Number K883909 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 1988
Decision Date December 27, 1988
Days to Decision 103 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary

Device Classification

Product Code DSS — Clip, Vascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3250

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